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COMPARATIVE STUDY
Jessica A Perhanidis, Linda Kalilani, Nicole M Zimmerman, Amanda Golembesky
PURPOSE: This retrospective real-world study compared overall survival (OS) between patients with BRCA wild-type (BRCAwt) recurrent epithelial ovarian cancer (OC) who received niraparib second-line maintenance (2LM) versus active surveillance (AS) using target trial emulation, cloning, inverse probability of censoring weighting (IPCW) methodology to minimize immortal time bias. METHODS: Eligible patients from a United States-based, deidentified, electronic health record-derived database were diagnosed with epithelial OC (January 1, 2011-May 31, 2021), were BRCAwt, and completed second-line (2L) therapy (January 1, 2017-March 2, 2022)...
September 2024: Pharmacoepidemiology and Drug Safety
#2
JOURNAL ARTICLE
Lingjie Shen, Erik Visser, Felice van Erning, Gijs Geleijnse, Maurits Kaptein
BACKGROUND: Comparing causal effect estimates obtained using observational data to those obtained from the gold standard (i.e., randomized controlled trials [RCTs]) helps assess the validity of these estimates. However, comparisons are challenging due to differences between observational data and RCT generated data. The unknown treatment assignment mechanism in the observational data and varying sampling mechanisms between the RCT and the observational data can lead to confounding and sampling bias, respectively...
September 2024: Pharmacoepidemiology and Drug Safety
#3
JOURNAL ARTICLE
Hedvig Nordeng, Angela Lupattelli, Hilde M Engjom, Marleen M H J van Gelder
PURPOSE: Pregnancies ending before gestational week 12 are common but not notified to the Medical Birth Registry of Norway. Our goal was to develop an algorithm that more completely detects and dates all possible pregnancy outcomes (i.e., miscarriages, elective terminations, ectopic pregnancies, molar pregnancies, stillbirths, and live births) by using diagnostic codes from primary and secondary care registries to complement information from the birth registry. METHODS: We used nationwide linked registry data between 2008 and 2018 in a hierarchical manner: We developed the UiO pregnancy algorithm to arrive at unique pregnancy outcomes, considering codes within 56 days as the same event...
September 2024: Pharmacoepidemiology and Drug Safety
#4
JOURNAL ARTICLE
Haerin Cho, Eunsun Lim, Hee-Jin Kim, Na-Young Jeong, Nam-Kyong Choi
BACKGROUND: Several cases of renal complications, including acute kidney injury (AKI), after influenza vaccination have been reported, but the association remains unproven. We evaluated the association between influenza vaccination and AKI occurrence among the Korean elderly in the 2018-2019 and 2019-2020 seasons. METHODS: We used a large database combining vaccination registration data from the Korea Disease Control and Prevention Agency and claims data from the National Health Insurance Service...
September 2024: Pharmacoepidemiology and Drug Safety
#5
JOURNAL ARTICLE
Kazuhiro Kajiyama, Maki Komamine, Naoya Horiuchi, Toyotaka Iguchi, Yoshiaki Uyama
No abstract text is available yet for this article.
September 2024: Pharmacoepidemiology and Drug Safety
#6
REVIEW
John Tazare, Shirley V Wang, Rosa Gini, Daniel Prieto-Alhambra, Peter Arlett, Daniel R Morales Leaver, Caroline Morton, John Logie, Jennifer Popovic, Katherine Donegan, Sebastian Schneeweiss, Ian Douglas, Anna Schultze
PURPOSE: There is increasing recognition of the importance of transparency and reproducibility in scientific research. This study aimed to quantify the extent to which programming code is publicly shared in pharmacoepidemiology, and to develop a set of recommendations on this topic. METHODS: We conducted a literature review identifying all studies published in Pharmacoepidemiology and Drug Safety (PDS) between 2017 and 2022. Data were extracted on the frequency and types of programming code shared, and other key open science practices (clinical codelist sharing, data sharing, study preregistration, and stated use of reporting guidelines and preprinting)...
September 2024: Pharmacoepidemiology and Drug Safety
#7
JOURNAL ARTICLE
Tamino Zappalà, Anton Pottegård, Carola A Huber, Daphne Reinau, Christoph R Meier, Julia Spoendlin
PURPOSE: Long-term use of hydrochlorothiazide increases the risk of non-melanoma skin cancer. We aimed to evaluate potential changes in the use of hydrochlorothiazide in Switzerland after a direct healthcare professional communication (DHPC) in November 2018 by Swissmedic. METHODS: We performed interrupted time-series analyses using a large Swiss healthcare claims database (2015-2021). Within monthly intervals, we quantified the total number of claims and the total dispensed 'defined daily doses' (DDD) for preparations containing (1) hydrochlorothiazide, (2) angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II-receptor blockers (ARB), (3) calcium-channel blockers (CCB) and (4) thiazide-like diuretics per 10 000 persons...
September 2024: Pharmacoepidemiology and Drug Safety
#8
JOURNAL ARTICLE
Julien Kirchgesner, Shirley V Wang, Sebastian Schneeweiss
No abstract text is available yet for this article.
September 2024: Pharmacoepidemiology and Drug Safety
#9
JOURNAL ARTICLE
Betty Chia-Chen Chang, I-Hua Lai, Yee-Yung Ng, Shiao-Chi Wu
BACKGROUND: Medication-related problem is a concerning issue in older adults with multimorbidity due to complexity of disease conditions and polypharmacy, and may lead to increase in risk for adverse health outcomes. This study aims to investigate the prevalence and associated factors of potentially inappropriate medication use among the growing population of older adults with multimorbidity in Taiwan. METHOD: The study population was composed of patients who were aged 65 years or older with multimorbidity (two or more chronic diseases) and had at least one outpatient clinic visit with drug prescription in 2018 identified from the Taiwan National Health Insurance Research Database...
September 2024: Pharmacoepidemiology and Drug Safety
#10
JOURNAL ARTICLE
Dony Patel, Sonia Guleria, Lina Titievsky, Susanna Flaherty, Nicholas Everage, Marta Korjagina, Sheuli Porkess, Tzuyung Douglas Kou, Deborah Layton
PURPOSE: There has been rapid growth in the variety and number of real-world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studies. This study aims to assess differences in RWD guidance and variability in current practice for identifying and assessing RWD for studies with regulatory purpose. METHODS: Key criteria for feasibility assessment were mapped against relevant regulatory guidance documents across US, EU, and Asia-Pacific regions...
September 2024: Pharmacoepidemiology and Drug Safety
#11
JOURNAL ARTICLE
Samantha Lane, Elizabeth Lynn, Saad Shakir
PURPOSE: Removing medicines from market may benefit public health by preventing adverse drug reactions (ADRs), which should be quantified. This study's aim was to identify a model to quantify the impact of medicines' marketing authorisation (MA) withdrawal and revocation in terms of preventing morbidity and mortality. METHODS: MA withdrawals and revocations for safety reasons in France, Germany and/or the United Kingdom between July 2012 and December 2016 were identified for prescription medicines...
September 2024: Pharmacoepidemiology and Drug Safety
#12
REVIEW
Chase D Latour, I-Hsuan Su, Megan Delgado, Virginia Pate, Charles Poole, Jessie K Edwards, Til Stürmer, Jennifer L Lund, Michele Jonsson Funk
PURPOSE: Although the limitations of hazard ratios (HRs) for quantifying treatment effects in right-censored data have been widely discussed, HRs are still preferentially reported over other, more interpretable effect measures. This may stem from the fact that there are few applied examples that directly contrast the HR and its interpretation with alternative effect measures. METHODS: We analyzed data from two randomized clinical trials comparing panitumumab plus standard-of-care chemotherapy (SOCC) with SOCC alone as first- and second-line treatment for metastatic colorectal cancer...
September 2024: Pharmacoepidemiology and Drug Safety
#13
REVIEW
Paulette Negron Ericksen, Firas Dabbous, Rajrupa Ghosh, Surbhi Shah, Xunming Sun, Emily Riehm Meier, Carmine Colavecchia
PURPOSE: Sickle cell disease (SCD) affects all organ systems and is characterized by numerous acute and chronic complications and comorbidities. Standardized codes are needed for complications/comorbidities used in real-world evidence (RWE) studies that rely on administrative and medical coding. This systematic literature review was conducted to produce a comprehensive list of complications/comorbidities associated with SCD, along with their diagnosis codes used in RWE studies. METHODS: A search in MEDLINE and Embase identified studies published from 2016 to 2023...
September 2024: Pharmacoepidemiology and Drug Safety
#14
REVIEW
Shahrzad Salmasi, Samuel Igweokpala, Antonios Douros, Nehal Islam, Jason G Andrade, Kristian B Filion
BACKGROUND: The association between opioid use and the risk of ventricular arrhythmias (VA) is poorly understood. AIMS: The objective of this study was to synthesize the evidence on the risk of VA associated with opioid use. MATERIALS & METHODS: We systematically searched the Cochrane Library, Embase, MEDLINE, and CINAHL databases in July 2022. Risk of bias was assessed using the Cochrane risk for bias tool for randomized controlled trials (RCTs) and ROBINS-I for observational studies...
August 2024: Pharmacoepidemiology and Drug Safety
#15
JOURNAL ARTICLE
Thomas G Boyce, David L McClure, Kayla E Hanson, Matthew F Daley, Malini B DeSilva, Stephanie A Irving, Lisa A Jackson, Nicola P Klein, Bruno Lewin, Joshua T B Williams, Jonathan Duffy, Michael M McNeil, Eric S Weintraub, Edward A Belongia
PURPOSE: Vaccine-associated enhanced disease (VAED) is a theoretical concern with new vaccines, although trials of authorized vaccines against SARS-CoV-2 have not identified markers for VAED. The purpose of this study was to detect any signals for VAED among adults vaccinated against coronavirus disease 2019 (COVID-19). METHODS: In this cross-sectional study, we assessed COVID-19 severity as a proxy for VAED among 400 adults hospitalized for COVID-19 from March through October 2021 at eight US healthcare systems...
August 2024: Pharmacoepidemiology and Drug Safety
#16
JOURNAL ARTICLE
Romin Pajouheshnia, Rosa Gini, Lia Gutierrez, Morris A Swertz, Eleanor Hyde, Miriam Sturkenboom, Alejandro Arana, Carla Franzoni, Vera Ehrenstein, Giuseppe Roberto, Miguel Gil, Miguel Angel Maciá, Wiebke Schäfer, Ulrike Haug, Nicolas H Thurin, Régis Lassalle, Cécile Droz-Perroteau, Silvia Zaccagnino, Maria Paula Busto, Bas Middelkoop, Karin Gembert, Francisco Sanchez-Saez, Clara Rodriguez-Bernal, Gabriel Sanfélix-Gimeno, Isabel Hurtado, Manuel Barreiro-de Acosta, Beatriz Poblador-Plou, Jonás Carmona-Pírez, Antonio Gimeno-Miguel, Alexandra Prados-Torres, Anna Schultze, Ella Jansen, Ron Herings, Josine Kuiper, Igor Locatelli, Janja Jazbar, Špela Žerovnik, Mitja Kos, Steven Smit, Sirje Lind, Andres Metspalu, Stefania Simou, Karin Hedenmalm, Ana Cochino, Paolo Alcini, Xavier Kurz, Susana Perez-Gutthann
PURPOSE: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct. METHODS: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop...
August 2024: Pharmacoepidemiology and Drug Safety
#17
JOURNAL ARTICLE
Helga Zoega, Michael O Falster, Malcolm B Gillies, Melisa Litchfield, Ximena Camacho, Claudia Bruno, Benjamin Daniels, Natasha Donnolley, Alys Havard, Andrea L Schaffer, Georgina Chambers, Louisa Degenhardt, Timothy Dobbins, Natasa Gisev, Rebecca Ivers, Louisa Jorm, Bette Liu, Claire M Vajdic, Sallie-Anne Pearson
BACKGROUND: The Medicines Intelligence (MedIntel) Data Platform is an anonymised linked data resource designed to generate real-world evidence on prescribed medicine use, effectiveness, safety, costs and cost-effectiveness in Australia. RESULTS: The platform comprises Medicare-eligible people who are ≥18 years and residing in New South Wales (NSW), Australia, any time during 2005-2020, with linked administrative data on dispensed prescription medicines (Pharmaceutical Benefits Scheme), health service use (Medicare Benefits Schedule), emergency department visits (NSW Emergency Department Data Collection), hospitalisations (NSW Admitted Patient Data Collection) plus death (National Death Index) and cancer registrations (NSW Cancer Registry)...
August 2024: Pharmacoepidemiology and Drug Safety
#18
JOURNAL ARTICLE
Rosa Gini, Romin Pajouheshnia, Lia Gutierrez, Morris A Swertz, Eleanor Hyde, Miriam Sturkenboom, Alejandro Arana, Carla Franzoni, Vera Ehrenstein, Giuseppe Roberto, Miguel Gil, Miguel Angel Maciá, Wiebke Schäfer, Ulrike Haug, Nicolas H Thurin, Régis Lassalle, Cécile Droz-Perroteau, Silvia Zaccagnino, Maria Paula Busto, Bas Middelkoop, Karin Gembert, Francisco Sanchez-Saez, Clara Rodriguez-Bernal, Gabriel Sanfélix-Gimeno, Isabel Hurtado, Manuel Barreiro-de Acosta, Beatriz Poblador-Plou, Jonás Carmona-Pírez, Antonio Gimeno-Miguel, Alexandra Prados-Torres, Anna Schultze, Ella Jansen, Ron Herings, Josine Kuiper, Igor Locatelli, Janja Jazbar, Špela Žerovnik, Mitja Kos, Steven Smit, Sirje Lind, Andres Metspalu, Stefania Simou, Karin Hedenmalm, Ana Cochino, Paolo Alcini, Xavier Kurz, Susana Perez-Gutthann
No abstract text is available yet for this article.
August 2024: Pharmacoepidemiology and Drug Safety
#19
JOURNAL ARTICLE
Minako Matsumoto, Sei Harada, Harufumi Ikuta, Miho Iida, Suzuka Kato, Mizuki Sata, Takuma Shibuki, Yoshiki Ishibashi, Naoko Miyagawa, Moeko Hisamatsu, Aya Hirata, Kazuyo Kuwabara, Ayano Takeuchi, Daisuke Sugiyama, Sayo Suzuki, Tomonori Nakamura, Tomonori Okamura, Toru Takebayashi
PURPOSE: Hypertension (HT), dyslipidemia (DL), and diabetes mellitus (DM) are major risk factors for cardiovascular diseases. Despite the wide availability of medications to reduce this risk, poor adherence to medications remains an issue. The aim of this study is to evaluate medication adherence of prevalent users in these disease medications (HT, DL, DM) using claims data. Factors associated with non-adherence were also examined. METHODS: Of 7538 participants of the Tsuruoka Metabolomics Cohort Study, 3693 (HT: 2702, DL: 2112, DM: 661) were identified as prevalent users of these disease medications...
August 2024: Pharmacoepidemiology and Drug Safety
#20
MULTICENTER STUDY
Anja Strangfeld, Yvette Meissner, Anja Weiß, Tatjana Rudi, Angela Zink, Tanja Ellmann, Tim Filla, Peer Aries, Xenofon Baraliakos, Christina Bungartz, Cornelia Glaser, Jörg Henes, Hanns-Martin Lorenz, Matthias Schneider, Susanna Späthling-Mestekemper, Christof Specker, Jutta G Richter, Rebecca Fischer-Betz
In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast-fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy...
August 2024: Pharmacoepidemiology and Drug Safety
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